Enrollment Completed in DRM01 Phase 2b Acne Trial; Topline Data Expected in 2Q16
Topline Data for DRM04 Phase 3 Hyperhidrosis Program Expected Mid-2016
MENLO PARK, Calif., Jan. 07, 2016 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, today announced an update for its DRM01 and DRM04 development programs. Patient enrollment has been completed for the DRM01 Phase 2b trial in patients with facial acne vulgaris, and the company expects to announce topline efficacy and safety results in the second quarter of 2016. In addition, based on current enrollment projections, topline results for Dermira’s two identical Phase 3 clinical trials for DRM04, a potential treatment for axillary hyperhidrosis (excessive underarm sweating), are expected mid-2016, compared to previous guidance of the second half of 2016.
“We are thrilled with the completion of patient enrollment for our Phase 2b trial for DRM01 in acne, the timing of which was consistent with our original expectations, and with enrollment for our DRM04 Phase 3 clinical trials, which has progressed faster than anticipated,” stated Luis Peña, executive vice president, Product Development of Dermira. “We believe these accomplishments position the company for a series of potentially value-creating events in 2016 and bring us closer to our goal of delivering new therapies for patients with dermatologic diseases. We very much look forward to providing further updates on our progress as the year unfolds.”
DRM01 Phase 2b Clinical Program
The DRM01 Phase 2b trial is a randomized, multi-center, double-blind, parallel-group, vehicle-controlled study designed to assess the safety and efficacy of DRM01 compared to vehicle in patients with facial acne vulgaris. The goal of the study is to establish the optimal dose for a potential Phase 3 program. In the Phase 2b trial, approximately 400 adult patients with moderate-to-severe facial acne vulgaris were randomized into five separate arms evaluating different DRM01 dosing regimens compared to vehicle. Approximately 300 patients will receive DRM01, with 100 patients in each of three DRM01 treatment arms, and approximately 100 patients will receive vehicle. Consistent with the preceding Phase 2a trial and in accordance with the published U.S. Food and Drug Administration (FDA) draft guidance for the development of acne drugs, the primary endpoints are the absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-point improvement from baseline in the five-point Investigator’s Global Assessment (IGA) score. Each endpoint will be measured at the end of the 12-week treatment period. The trial is being conducted at approximately 30 sites in the U.S. and Canada. Pending the successful completion of the Phase 2b trial and all applicable non-clinical work, Dermira expects to include both adult and adolescent patients in its Phase 3 program.
DRM04 Phase 3 Clinical Program
The DRM04 Phase 3 program is designed to assess the safety and efficacy of DRM04 to support a potential New Drug Application (NDA) submission to the FDA. The program consists of two pivotal studies, ATMOS-1 and ATMOS-2, to assess the safety and efficacy of DRM04 compared to vehicle and an open-label study, ARIDO, to assess the long-term safety of DRM04. The program is being conducted at approximately 60 trial sites in the U.S. and Germany.
The ATMOS-1 and ATMOS-2 studies are identical, randomized, double-blind, vehicle-controlled trials enrolling a total of approximately 660 adult and adolescent (ages nine and older) patients with primary axillary hyperhidrosis. In each of these trials, 220 patients will receive DRM04 and 110 patients will receive vehicle. Patients are instructed to apply the study product to each axilla (underarm) once daily for four weeks using topical wipes containing either DRM04 or vehicle only. The co-primary endpoints are the average absolute change from baseline in gravimetrically-measured sweat production and the proportion of patients who achieve at least a four-point improvement from baseline in disease severity as measured by the Axillary Sweating Daily Diary (ASDD), the company’s proprietary patient-reported outcome (PRO) instrument. Secondary efficacy endpoints include (1) the proportion of subjects who have at least a two-grade improvement from baseline in their score on the Hyperhidrosis Disease Severity Scale (HDSS), wherein patients rate the severity of their disease on a four-point scale, and (2) the proportion of subjects with at least a 50% reduction from baseline in gravimetrically-measured sweat production. Both the primary and secondary endpoints will be assessed at the end of the four-week treatment period.
Topline results from the ATMOS-1 and ATMOS-2 trials are now expected mid-2016. In the open-label ARIDO study assessing the long-term safety of DRM04, patients from either of the ATMOS Phase 3 studies are permitted to continue to receive active treatment for up to an additional 44 weeks from the end of the 4-week treatment periods in the ATMOS studies. Pending the successful completion of these studies and other registration-enabling activities, Dermira expects to submit an NDA to the FDA in the second half of 2017.
DRM01 is a novel, topical, small-molecule sebum inhibitor in development for the treatment of acne. Sebum is an oily substance made up of lipids produced by glands in the skin called sebaceous glands, and excessive sebum production is an important aspect of acne that is not addressed by available topical therapies. DRM01 is designed to exert its effect by inhibiting acetyl coenzyme-A carboxylase, an enzyme that plays an important role in the synthesis of fatty acids, a type of lipid that represents an essential component of the majority of sebum lipids.
DRM04 is a topical, small-molecule, anticholinergic product in clinical development for the treatment of hyperhidrosis. DRM04 is designed to inhibit sweat production by blocking the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
Dermira is a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases. Dermira’s portfolio of five product candidates targets significant market opportunities and includes three late-stage product candidates: CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe plaque psoriasis; DRM04, in Phase 3 development for the treatment of axillary hyperhidrosis; and DRM01, in Phase 2b development for the treatment of acne. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to the goal of delivering new therapies for patients with dermatologic diseases; the use of DRM01 as a safe and effective treatment for acne and DRM04 as a safe and effective treatment for hyperhidrosis; the description of the DRM01 Phase 2b program; the design of a potential DRM01 Phase 3 program; the description of and enrollment expectations for the DRM04 Phase 3 studies; the successful completion of, and timing expectations for the receipt and announcement of topline efficacy and safety data from, the DRM01 Phase 2b and DRM04 Phase 3 studies; the company’s anticipated position and events in 2016; and the potential NDA submission to the FDA for DRM04 and the expected timing of such submission. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcomes of our clinical trials; our dependence on third-party clinical research organizations, manufacturers and suppliers; our ability to obtain regulatory approval for our product candidates; and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Report on Form 10-Q and other filings Dermira makes with the Securities and Exchange Commission from time to time for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. We undertake no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
Chief Operating Officer and Chief Financial Officer
Robert H. Uhl